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Mantra Meditation in Major Depression (MAMED)

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ClinicalTrials.gov Identifier: NCT03004430
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
University Hospital Dresden
Information provided by (Responsible Party):
Diakonie Kliniken Zschadraß

Brief Summary:
To evaluate effects of mantra meditation on depressive symptoms if applied as adjunctive therapy to psychotherapy and/or antidepressant drugs and to explore if meditation leads to increased spirituality as a potential mediating factor of positive mental health.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Mantra Meditation Behavioral: Progressive Muscle Relaxation Not Applicable

Detailed Description:

Primary objective To measure the difference in efficacy between treatment as usual (TAU) + Mantra meditation (MAM) 20min per day and TAU + progressive muscle relaxation (PMR) 20min per day in the treatment of depressive symptoms in patients with Major Depression after inpatient treatment, after 3 months and after 6 months of treatment as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS).

Secondary objectives (exploratory)

  1. Differences between and within groups in self-rated depression, rumination, automatic negative thinking or trait-anxiety.
  2. Differences between and within groups in measures of spirituality.
  3. Correlation between measures of spirituality and change of psychometric scores.
  4. Change in stress response and relaxation response after inpatient treatment, compared to baseline.
  5. Difference in adherence and depth of practice between groups and within groups and correlation to psychometric outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mantra Meditation as Adjunctive Therapy in Major Depression: a Randomized Controlled Trial
Actual Study Start Date : January 12, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MAM
Mantra Meditation Group
Behavioral: Mantra Meditation
Silent mantra meditation with spiritual mantra

Active Comparator: PMR
Progressive Muscle Relaxation Group
Behavioral: Progressive Muscle Relaxation
Progressive Muscle Relaxation




Primary Outcome Measures :
  1. MADRS / SIGMA [ Time Frame: 6 months ]
    The clinician-rated Montgomery and Asberg Depression Rating Scale (MADRS) [reproduced in the Appendix to this chapter] was developed in the late 1970s (Montgomery & Asberg, 1979) and this 10-item scale was designed to be sensitive to the effects of antidepressant medications, primarily tricyclic antidepressants. One of the original goals of the MADRS was to obtain an instrument that could be used by both psychiatrists and professionals without a specific or with minimal psychiatric training. From the original report of the MADRS, the inter-rater reliability ranged from 0.89 to 0.97. However, in a German study, significant differences resulted when the same patient was rated by various groups of caregivers (as described in Cusin, Yang, Yeung, & Fava, 2010). Hence, a structured interview guide (SIGMA) that has been developed for the MADRS (Williams, Kobak, & Montgomery, 2008) will be used in this study by trained psychologists exclusively.


Secondary Outcome Measures :
  1. STAI-T [ Time Frame: 6 months ]
    The State-Trait Anxiety Inventory (STAI) is an introspective psychological inventory consisting of 40 self-report items pertaining to anxiety affect. The STAI was constructed by Charles Spielberger, R.L. Gorsuch, and R.E. Lushene, based on the state-trait distinction proposed by Raymond Cattell in 1961. Their goal was to compile a set of items that could measure anxiety at both poles of the normal affect curve (state vs. trait). The STAI purports to measure one's conscious awareness at two extremes of anxiety affect, labeled state anxiety (A-state), and trait anxiety (A-trait), respectively. Affectivity ranges from immediate, transitory emotional states, through longer-lasting mood states, through dynamic motivational traits, ranging all the way up to relatively enduring personality traits. Higher STAI scores suggest higher levels of anxiety (C D Spielberger & Sydeman, 1994; Charles D Spielberger, 1987).

  2. PTQ [ Time Frame: 6 months ]
    The PTQ (Ehring et al., 2011) is a 15-item questionnaire assessing the tendency to engage in repetitive negative thinking independent of a disorder-specific content. Items are rated on a scale ranging from 0 (never) to 4 (almost always). The PTQ consists of three subscales: Core features of repetitive negative thinking, perceived unproductiveness of repetitive negative thinking , and repetitive negative thinking capturing mental capacity (sample item: 'My thoughts prevent me from focusing on other things'.). Confirmatory factor analysis provides support for a 3-factor solution. Assessment of the psychometric properties of the PTQ, including the Dutch version (Ehring, Raes, Weidacker, & Emmelkamp, 2012), has demonstrated high internal consistency (a = .93-.95), acceptable test-retest reliability (r = .69-.75), good convergent validity as well as good predictive validity in the prediction of symptom levels of anxiety and depression.

  3. RSQ [ Time Frame: 6 months ]
    The rumination scale of the Response Style Questionnaire (RSQ; Nolen-Hoeksema, 1991; German version: Kühner, Huffziger, & Nolen-Hoeksema, 2007) was used to assess repetitive negative thinking in the form of depressive rumination. The questionnaire consists of 22 items describing the individual's response to sad or depressed mood (e.g., "Think about how passive and unmotivated you feel") that are rated on a scale from '1' (never) to '4' (always). The RSQ is regarded as the standard measure of rumination; it has been used widely in clinical as well as non-clinical populations and has demonstrated high reliability and validity (Kühner et al., 2007, Luminet, 2004 and Nolen-Hoeksema, 2004).

  4. ASP [ Time Frame: 6 months ]
    Aspects of Spirituality (ASP) . The ASP questionnaire was developed to measure a wide variety of vital aspects of spirituality beyond conventional conceptual boundaries in secular societies. Both expert representatives of various spiritual orientations and also atheists were asked which aspects of spirituality are relevant to them (Büssing, 2006). Identified motifs we condensed to 40 items of the Aspects of Spirituality (ASP 1.0) questionnaire (7 factors; Cronbach ́s alpha = .94) (Büssing et al., 2007) which differentiates and quantifies cognitive, emotional, intentional and action-oriented matters of theism/belief, (esoteric) transcendence, existentialism, humanism etc. The reliable and valid instrument is suited to be used in health care research (Büssing et al. 2007).

  5. SpREUK [ Time Frame: 6 months ]
    The SpREUK was developed to investigate whether or not patients with chronic diseases living in secular societies rely on spirituality as a resource to cope with illness. The SpREUK questionnaire relies on essential motifs found in counseling interviews with chronic disease patients (i.e., having trust/faith; search for a transcendent source to rely on; reflection of life and subsequent change of life and behavior). The instrument is suited to be used in health care research (A Büssing, Ostermann, & Matthiessen, 2005).

  6. EEQ [ Time Frame: 6 months ]
    A new instrument for the measurement of exceptional experiences, which considers both frequency and individual evaluation of exceptional experiences. A principal component factor analysis extracted four factors (positive spiritual experiences, experiences of deconstruction/ ego loss, psychopathological experiences and dream-type experiences), which explain 49% of the variance. The 25-item short form of the instrument shows good psychometric properties (range for Cronbach's alpha: r = 0.67-0.89, range for test- retest reliability after 6 months r = 0.66-0.87). The instrument shows adequate discriminant and convergent validity (Sense of Coherence, Social Support, Mental Distress and Transpersonal Trust) and can discriminate between spiritual practising and non practising individuals (Kohls & Walach, 2006).

  7. ICPH [ Time Frame: 6 months ]
    Specific mind-body-interventions (i.e., yoga, quigong, therapeutic eurythmy, mindfulness-based meditation etc.) require an active (emotional) engagement of individuals practicing it. Apart from direct physiological effects, an active emotional engagement seems to be important. This type of engagement can be conceptualized as an `inner involvement ́ (Büssing et al. 2011). Lacking this attitude in terms of an inner resistance towards the practices may lead to reduced engagement, adherence, and thus treatment efficacy. The ICPH scale ("Inner Correspondence / Peaceful Harmony with Practices") was developed to measure this `inner correspondence in clinical studies addressing the efficacy of mind body practices involving physical movements. While it is suitable for progressive muscle relaxation, wording needs to be adjusted for mantra meditation (Arndt Büssing, Edelhuser, Weisskircher, Fouladbakhsh, & Heusser, 2011).

  8. HRV [ Time Frame: 1 month ]
    Change of Cardiovagal Index (CVI), a normalized measure of heart rate variability (HRV), in stress response and relaxation response after inpatient treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Inpatients of open psychiatric ward
  2. Written informed consent by patients who are competent to consent to study participation
  3. Diagnosis of current episode of major depression as defined by DSM-IV criteria and diagnosed via structured interview (SKID) by a trained psychiatrist or psychologist. DSM-IV codes: 296.22, 296.23, 296.32, 296.33. Corresponding ICD-10 codes: F32.1, F32.2, F33.1, F33.2.
  4. Male or female ≥18 years of age
  5. BDI-II >= 20
  6. Patients must be able to sit in a chair for at least 20 minutes
  7. Patients live in the catchment area of the hospital

Exclusion Criteria:

Patients will be excluded for ANY ONE of the following reasons:

  1. Any other current major psychiatric disorder is an exclusion criterion EXCEPT for the following:

    • Abuse of nicotine or dependence of nicotine;
    • Agoraphobia with or without Panic Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder, Specific Phobia, Social Phobia
    • Hypochondriasis, Pain Disorder, Somatization Disorder, Undifferentiated Somatoform Disorder
    • Sexual and Gender Identity Disorders
    • Eating disorders
  2. Psychotic symptoms that are not compatible with diagnosis of unipolar depression
  3. Acute suicidality
  4. Diagnosis affecting cortisol levels such as type I diabetes mellitus, cancer, asthma, chronic hepatitis, chronic fatigue syndrome, or regular use of medications having an immuno-modulary effect (e.g. cytotoxic chemotherapy, corticosteroids, interferons);
  5. Current practice of other forms of Mantra repetition such as the rosary, chanting, or Transcendental Meditation
  6. Current participation in another trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004430


Contacts
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Contact: Holger C Bringmann, Dr. med. +49-34381-87313 h.bringmann@diakoniezschadrass.de

Locations
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Germany
Diakoniekliniken Zschadraß Recruiting
Colditz, Sachsen, Germany, 04680
Contact: Holger C Bringmann, Dr. med.       h.bringmann@diakoniezschadrass.de   
Sponsors and Collaborators
Diakonie Kliniken Zschadraß
University Hospital Dresden
Investigators
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Principal Investigator: Holger C Bringmann, Dr. med. Diakoniekliniken Zschadraß

Publications of Results:
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Responsible Party: Diakonie Kliniken Zschadraß
ClinicalTrials.gov Identifier: NCT03004430     History of Changes
Other Study ID Numbers: MAMED001
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Diakonie Kliniken Zschadraß:
Mantra
Meditation
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders